Simplified Antibiotic Therapy for Sepsis in Young Infants (SATT)

This study has been completed.
Sponsor:
Collaborators:
Save the Children
World Health Organization
London School of Hygiene and Tropical Medicine
Emory University
Information provided by (Responsible Party):
Anita Kaniz Mehdi Zaidi, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01027429
First received: December 7, 2009
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by families.


Condition Intervention Phase
Neonatal Sepsis
Sepsis
Infection
Drug: procaine penicillin and gentamicin
Drug: amoxicillin and gentamicin
Drug: procaine penicillin, gentamicin, amoxicillin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Simplified Antibiotic Regimens for the Management of Sepsis in Young Infants in First-level Facilities: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Treatment failure [ Time Frame: within 7 days of enrolment ] [ Designated as safety issue: Yes ]

Enrollment: 2543
Study Start Date: December 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: procaine penicillin and gentamicin
Procaine penicillin, 50,000 IU/kg by intramuscular injection plus gentamicin, 5 mg/kg intramuscular injection, both given once daily for 7 days
Drug: procaine penicillin and gentamicin
procaine penicillin 50,000 units/kg by intramuscular injection once daily for 7 days; gentamicin, 5 mg/kg once daily by intramuscular injection for 7 days
Drug: procaine penicillin, gentamicin, amoxicillin
procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.
Experimental: Amoxicillin and gentamicin
Oral amoxicillin (80-90 mg/kg) divided twice daily and intramuscular gentamicin, 5 mg/kg once daily, both given for 7 days
Drug: amoxicillin and gentamicin
oral amoxicillin 80-90 mg/kg divided in two doses for 7 days intramuscular gentamicin, 5 mg/kg once daily for 7 days
Drug: procaine penicillin, gentamicin, amoxicillin
procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.
Experimental: procaine penicillin, gentamicin, and amoxicillin
procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.
Drug: procaine penicillin, gentamicin, amoxicillin
procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.

Detailed Description:

Primary Objective

To evaluate if out-patient (clinic-based) therapy of young infants with possible serious bacterial infection with 7 days of intramuscular procaine penicillin and gentamicin (reference therapy) is equivalent to:

  • (1) injectable gentamicin once daily and oral amoxicillin twice daily for seven days;
  • (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days; and

Hypothesis

The proportion of babies who fail therapy at (or before 7) days will be 10% in each group. A 5% or less difference in failure rates will be considered equivalent.

Study Design

This will be a randomized, three arm, open-label equivalence trial among young infants, 0-59 days of age who are diagnosed as having possible serious bacterial infection in one of the Karachi field clinics, and whose families refuse facilitated hospital referral, and the infants meet other specified inclusion criteria.

Eligible young infants will be recruited from among those referred to the clinics by trained community health workers as having clinical signs predictive of possible serious illness during regular home visits in the surveillance area, or those presenting directly to the clinics from the areas under pregnancy and newborn surveillance. A diagnosis of possible sepsis will be made by clinicians if specified clinical criteria are met.

  Eligibility

Ages Eligible for Study:   up to 59 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion Criteria

    • Infants 0-59 days old who are residents of catchment population of the study hospitals or clinics
    • One or more of the following five signs: severe chest in-drawing, axillary temperature >38.0C or <35.50 C, movement only when stimulated, and history of feeding problems (confirmed by poor suck on feeding assessment)
    • Family refuses recommended hospitalization or hospitalization otherwise not feasible
    • Informed consent by a legal guardian.
  • Exclusion Criteria:

Very severe infection/disease characterized by presence of any of the following signs (unconscious, convulsions, unable to feed, apnea, unable to cry, cyanosis, bulging fontanel, prolonged capillary refill, major congenital malformations, major bleeding, surgical conditions needing hospital referral, persistent vomiting defined as vomiting following three attempts to feed the baby within ½ hour)

  • Very low birth weight: weight <1500
  • Hospitalization for illness in the last two weeks
  • Previous inclusion in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027429

Locations
Pakistan
Anita K M Zaidi
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Save the Children
World Health Organization
London School of Hygiene and Tropical Medicine
Emory University
  More Information

No publications provided by Aga Khan University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anita Kaniz Mehdi Zaidi, Professor and Chair, Department of Paediatrics and Child Health, Aga Khan University
ClinicalTrials.gov Identifier: NCT01027429     History of Changes
Other Study ID Numbers: SC134GL50124
Study First Received: December 7, 2009
Last Updated: January 15, 2014
Health Authority: United States: International Technical Steering Committee appointed by Save the Children, USA, and
Switzerland: World Health Organization

Keywords provided by Aga Khan University:
infant
newborn
sepsis
infection
community

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Amoxicillin
Gentamicins
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine
Procaine
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014